National Association of Testing Authorities, Australia
Scope of Accreditation
Therapeutic Goods Administration
Site
Laboratories Branch Biotherapeutics
Accreditation No.
2432
Site No.
2665
Date of Accreditation
30 Jun 1989
Contact
Availability
Services conditionally available to external clients
Scope of Accreditation
ISO/IEC 17025 (2017)
Healthcare, Pharmaceutical and Media Products
Service | Product | Determinant | Technique | Procedure |
---|---|---|---|---|
Biological analysis of human and veterinary medicines including vaccines | Biological medicines; Vaccines | Content; Identity; Potency; Purity | Cell culture; Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Immunodiffusion; Mass spectrometry (MS); Polymerase chain reaction (PCR) | By BP, PhEur, USP, manufacturer and in-house methods for Capillary electrophoresis, Cell culture, Electrophoresis, ELISA, Enzyme activity, General laboratory procedures, HPLC, Influenza, PCR and Sysmex |
Pharmaceuticals | LAL bacterial endotoxin | Limulus amoebocyte lysate (LAL) | By BP, PhEur, USP, manufacturer and in-house methods for Bacterial Endotoxin |
The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.
Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.
Accreditation No.
2432
Site No.
2665
Print date
08 Dec 2024